A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04991766
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
- Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.
- Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders
- Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description [¹⁴C]-LY3484356 (Part 1) [¹⁴C]-LY3484356 Single dose of \[¹⁴C\]-LY3484356 administered orally. LY3484356 + [¹⁴C]-LY3484356 (Part 2) LY3484356 Single dose of LY3484356 administered orally followed by Single dose of \[¹⁴C\]-LY3484356 administered intravenously (IV). LY3484356 + [¹⁴C]-LY3484356 (Part 2) [¹⁴C]-LY3484356 (IV) Single dose of LY3484356 administered orally followed by Single dose of \[¹⁴C\]-LY3484356 administered intravenously (IV).
- Primary Outcome Measures
Name Time Method Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Predose up to Day 12 post dose Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Predose up to Day 12 post dose Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Pharmacokinetics (PK): Absolute Bioavailability of LY3484356 Predose up to Day 9 post dose PK: Absolute Bioavailability of LY3484356
- Secondary Outcome Measures
Name Time Method PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 Predose up to Day 12 post dose PK: (AUC (0-∞)) of Total Radioactivity, LY3484356 and \[¹⁴C\]-LY3484356
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable). Predose up to Day 12 post dose Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable).
PK: Maximum Concentration (Cmax) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 Predose up to Day 12 post dose PK: Cmax of Total Radioactivity, LY3484356 and \[¹⁴C\]-LY3484356
Total Number of Metabolites of LY3484356 Predose up to Day 12 post dose Total Number of Metabolites of LY3484356
Trial Locations
- Locations (1)
LabCorp CRU, Inc.
🇺🇸Madison, Wisconsin, United States